FDA Review Panel · HO

FDA 510(k) General Hospital Devices

FDA 510(k) General Hospital Devices - Regulatory Overview

FDA 510(k) general hospital devices cover a broad range of equipment used across hospital departments. The FDA review panel code is HO.

This is one of the largest 510(k) categories, with 17,707 submissions since 1976. It includes:

  • Infusion and delivery systems - IV pumps, syringe drivers, enteral feeding
  • Vascular access devices - IV catheters, PICC lines, ports
  • Hospital beds and patient handling - adjustable beds, transfer devices
  • Sterilization and disinfection - autoclaves, chemical disinfectants, endoscope reprocessors
  • Wound care - negative pressure wound therapy, dressings

17791
Total
17765
Cleared
158d
Avg (2y)
1976
Since
11936 General Hospital devices
6626–6650 of 11936
Cleared Jun 08, 2001
AIRLIFE HEPA FILTER
K011132 · Allegiance Healthcare Corp.
CAH · Filter, Bacterial, Breathing-circuit · 56d
Cleared Jun 07, 2001
NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5
K011377 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 34d
Cleared Jun 07, 2001
NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW
K011371 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 34d
Cleared Jun 07, 2001
NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG
K011370 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 34d
Cleared Jun 07, 2001
ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER
K010862 · Allegiance Healthcare Corp.
KGO · Surgeon's Gloves · 77d
Cleared Jun 07, 2001
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
K010799 · Standard Textile Co., Inc.
FYA · Gown, Surgical · 83d
Cleared Jun 06, 2001
STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TESTED
K010856 · Brightway Holdings Sdn. Bhd.
LYY · Latex Patient Examination Glove · 76d
Cleared Jun 05, 2001
SIMPLICITY SOFT QD SILVER INFUSION SET
K011580 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 14d
Cleared Jun 05, 2001
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
K011442 · Abbott Laboratories
FRN · Pump, Infusion · 26d
Cleared Jun 05, 2001
STRYKER PAINPUMP PCA
K003543 · Stryker Instruments
FRN · Pump, Infusion · 200d
Cleared May 31, 2001
AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY
K010865 · STERIS Corporation
FLE · Sterilizer, Steam · 70d
Cleared May 29, 2001
MEDISYSTEMS LUER ACCESS INJECTION SITE
K010279 · Medisystems Corp.
FPA · Set, Administration, Intravascular · 119d
Cleared May 25, 2001
EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN LABELING (200
K011376 · Yty Industry (Manjung) Sdn Bhd
LYY · Latex Patient Examination Glove · 21d
Cleared May 25, 2001
POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES
K011186 · Allegiance Healthcare Corp.
LYZ · Vinyl Patient Examination Glove · 37d
Cleared May 24, 2001
INFANT LIMB HOLDER, MODELS 306080 & 306081
K010818 · Skil-Care Corp.
FMQ · Restraint, Protective · 66d
Cleared May 18, 2001
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
K010644 · Skil-Care Corp.
FMQ · Restraint, Protective · 74d
Cleared May 15, 2001
COLLEAGUE VOLUMETRIC INFUSION PUMP
K010566 · Baxter Healthcare Corp
FRN · Pump, Infusion · 78d
Cleared May 08, 2001
POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED
K011271 · Perusahaan Getah Asas Sdn. Bhd.
LYY · Latex Patient Examination Glove · 12d
Cleared May 03, 2001
LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER)
K010863 · La Glove (M) Sdn. Bhd.
LZA · Polymer Patient Examination Glove · 42d
Cleared May 03, 2001
POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0
K010483 · Pt. Medisafe Technologies
LYY · Latex Patient Examination Glove · 72d
Cleared May 01, 2001
ABBOTT ACCLAIM ENCORE, MODEL 12237
K011096 · Abbott Laboratories
FRN · Pump, Infusion · 21d
Cleared May 01, 2001
MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)
K010439 · Terang Nusa Sdn Bhd
KGO · Surgeon's Gloves · 78d
Cleared May 01, 2001
MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS)
K010438 · Terang Nusa Sdn Bhd
KGO · Surgeon's Gloves · 77d
Cleared May 01, 2001
ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB
K002718 · Tillotson Healthcare Corp.
LYY · Latex Patient Examination Glove · 243d
Cleared Apr 30, 2001
SIMPLICITY WING INFUSION SET
K010886 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 38d

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All categories 11936 LZA Polymer Patient Examination Glove 1057 FPA Set, Administration, Intravascular 800 LYY Latex Patient Examination Glove 672 FRN Pump, Infusion 605 FLL Continuous Measurement Thermometer 557 LYZ Vinyl Patient Examination Glove 514 FXX Mask, Surgical 511 FMF Syringe, Piston 498 FMI Needle, Hypodermic, Single Lumen 491 FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days 416 KGO Surgeon's Gloves 366 KKX Drape, Surgical 276 LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days 264 LJT Port & Catheter, Implanted, Subcutaneous, Intravascular 242 KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 238